oversight

Grant Fraud Human Subject Reg. Violations

Published by the National Science Foundation, Office of Inspector General on 1995-10-16.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

,-
                          CLOSEOUT FOR M92010005



                 Associate Provost for Research at
investigation of alleged misconduct by   I -1
                                                    -
     This case was brought to OIG on October 9, 1991, when Dr.
University, informed us that the university was initiating an
Attached are the OIG investigation report, including its appendices
and the letter of reprimand from NSF to the subject, which explains
NSF1s adjudicative decision. These documents explain the actions
subsequently taken by OIG and NSF in this case.


 cc:   Deputy AIG-0, IG




                               page 1 of 1
              .   .

 .   .                     -   .   NATIONAL SCIENCE FOUNDATION'
                                       4201 WILSON BOULEVARD
                                      ARLINGTON, VIRGINIA 22230




   OFFlCE OF M E
ASSISTANT DIRECTOR
BIOLOGICALSC~WCES




            -
CERTIFIED MAIL        --       RETURN RECEIPT REOUESTED




              Re : Notice of Misconduct Determination
Dear Dr.
The National Science Foundation1s Office of Inspector General (OIG)
issued an Investigation Report on June 28, 1995, in which it found
that you committed misconduct in science.              Based upon
investigations conducted by the Special Review Board and the
Institutional Review Board (IRB) of the -university,
and its own independent investigation, the OIG found that you
committed serious violations of the requirements for the protection
of human subjects. We have reviewed the report and conclude that
you have committed miscbnduct in science.
Misconduct and Pro~osedAction
Under NSF's misconduct in science and engineering regulations,
"misconduct" is defined to include "fabrication, falsification,
plagiarism; or other serious deviations from accepted practices in
proposing, carrying out or reporting results from activities funded
by NSF." 45 CFR §689.1(a).
The Agency's administrative record establishes that you failed to
comply with the IRB guidelines by failing to respond to the IRB1s
requests for consent and assent forms, failing to pay research
participants as promised, and failing to.obtain consent from a
school system to perform research on their students. You violated
the usual and customary practices for treating human subjects.
This cons'titutes a serious deviation from accepted practices for
the treatment of human subjects, and, therefore, scientific
misconduct.
NSF's regulations establish three categories of actions (Group I,
I1 and 111) that can be taken in response to a finding of
misconduct. 45 CFR §689.2(a). Group I actions include issuing a
letter of reprimand; conditioning awards on prior approval of
particular activities from NSF; and requiring certification on t h e
accuracy of reports or assurances of compliance with particular
requirements. 4 5 CFR §689.2(a)(1). Group I1 actions include

                       Telephone (703)306-1400          FAX (703)306-0343
        Page 2
        restrictions on designated activities or expenditures and special
        reviews of requests for funding. 45 CFR 5689.2(a) (2). Group I11
        actions include suspension or termination of awards; debarment or
        suspension from participation in NSF programs, and prohibitions on
        participation as NSF reviewers, advisors, or consultants. 45 CFR
        5689.2 (a)(3).
        In deciding what response is appropriate, NSF considered the
        seriousness of the misconduct; whether it was deliberate or
        careless; whether it was an isolated event or part of a pattern;
        and whether the misconduct affects only certain funding requests or
        has implications for any application for funding involving the
        subject of the misconduct finding. See 45 CFR 5689.2 (b).
        In this case, we do not believe that your failure to pay research
        partici~ants.was a pattern of non-payment. However, the record
        demonstrates that your failure to comply with the IRB requirements
        for protection of human subjects was part of a pattern of non-
        compliance with NSF grant conditions. You violated NSF grant
        conditions by using NSF funds to perform research other than that
        proposed to NSF, misusing funds that were allocated for payment of
        research participants, failing to secure the safekeeping or return
        of University owned equipment purchased under the NSF grant, and
        failing to cooperate with                           Special Review
        Board and IRB inquirieud         *investigations concerning your
        activities.
        Based upon the above facts, I conclude that as a condition to your
        receipt of future NSF funds, special grant conditions must be
        implemented to protect NSFts interests as well as those of human
        subjects. Accordingly, I will require, until January 1, 1998, that
        NSF, before making an award in which you are named as the principal
        investigator, shall require the grantee institution to establish
        and enforce special procedures to monitor your compliance with
,       NSF's grant conditions. These procedures shall, at a minimum,
        provide for monitoring of your compliance with human subjects
        research requirements and proper distribution of any federal funds
        under your direct control. Such procedures must be approved in
        advance by NSF.
        procedures Governinq Appeals
        Under NSF1s regulations, you have 30 days after receipt of this
        letter to submit an appeal of this decision, in writing, to the
    I   Director of the Foundation. 45 CFR §689.9(a). Any appeal should
        be addressed to the Director of the National Science Foundation,
        4201 Wilson Boulevard, Arlington, Virginia 22230.        For your
        information we are attaching a copy of the applicable regulations
and of OIG' s investigative report. If you have any questions about
the foregoing, please call Lawrence Rudolph, General Counsel, at
(703) 306-1060.

                             Sincerely,


                             Mary E. Clutter
                             Assistant Director


Attachments (2)
Misconduct in Science Regulations
Investigation Report
                                NSF OIG REPORT



                        OIG Case Number M92010005




This document is loaned to you for official use only. It remains the property of the Office
of Inspector General. It may not be reproduced. It may be disclosed outside of NSF only
by the Inspector General, pursuant to the Freedom of Information and Privacy Acts, 5
U.S.C. $8552, 552a.
        REPORT OF INVESTIGATION INTO AN ALLEGATION OF MISCONDUCT IN
                          SCIENCE AND ENGINEERING

                                     SUMMARY
         The Office of Inspector General (OIG) has determined that
  - 1               (the subject) committed serious violations of human
    subjects regulations; mishandled funds and equipment that were part
    of an NSF award; did not, during the time she was receiving NSF
    support, conduct the research she proposed to NSF; and did not
    cooperate with inquiries and investigations concerning her
    activities.    These conclusions are based on investigations
    performed by the subject's former university and by OIG.        OIG
    recommends that NSF find that the subject's violations of human
    subjects regulations are misconduct and take the following actions
    as a final disposition in this case. The subject should be told
    that NSF has made a finding of misconduct and should receive a
    letter of reprimand from the NSF Office of the Director. Until
    January, 1998, before making an award in which the subject is named
    principal investigator, NSF1s Office of the Director, in
    consultation with scientists knowledgeable about research involving
    human subjects,     should require that the grantee institution
    establish and enforce special procedures to monitor the subject's
    compliance with NSF1s grant conditions, including, but not
    necessarily limited to, procedures for monitoring her compliance
    with human subjects replations at the grantee institution.


                TBE UNIVERSITY'S    INQUIRY AND INVESTIGATION

          Early in 1990, members of at least three families complained
, -promised
   to a                          (the University) that they had been
            payments for their participation in experiments run by Dr.
    -
    (
    t
    h
    e                   subject) and had not been paid. The subject's
    experiments were performed under NSF award, 1-4            entitled
                                                          .At the time
                                                        -t
                                                         n) , where she
                                                        ter repeated,
    unsuccessful efforts by officials at the University to verify and
    settle the participants1 claims for payment, the chair of the
    subject's department referred the matter to the University's
    Research Integrity Committee, which conducted an inquiry. The
    committee, in turn, referred the case to a Special Review Board,
    which conducted an investigation.
         A copy of the Board's investigation report appears in
    Appendix 1. The Board's report contains sixteen appendices, each
    identified by a letter (A-P). References to numbered appendices
                                   page 1 of 24
     indicate appendices to OIG's investigation report;            where
     appendices are identified by a letter, this indicates that they are
     appendices to the Special Review Board (the ~oard)report and can
     be found in Appendix 1.      Quotations in OIGfs report, unless
     otherwise indicated, are from the Special Review Board report or
     its appendices, and page references refer to that report as well.
          The Board report concluded (pages 22-23) that the subject had
     committed Itscientificmisc~nduct'~ in the following respects:
          1.   She had !Imisused funds advanced to her for the purpose of
               paying human research subjectsm and "repeatedly and
               significantly1!violatedprocedures she and the university
               had established governing her use of her research
               checking account.
          2.   Using grant funds, the subject made an unjustified
               purchase of video equipment and failed "to secure the
               safekeeping of the equipment." Although the equipment
               was University property, the Board could not locate it.
          3.     The subject "violated the usual and customary
                 requirements for the treatment of human subjects.I1 The
                 Board referred allegations of human subjects violations
                 to the University Institutional Review Board for the
                                                  .
               . Protection of Human Subjects (IRB) The IRB found seven
                 instances in which the subject violated its guidelines.
                 A copy of the IRB report appears in Appendix 2.
          4.   There was I1no evidence1!that the subject had performed
               the research she had proposed to NSF.
          5.   The subject did not cooperate with the Special Review
               Board investigation or with other related inquiries,
               including the IRB inquiry.
li        The Bsard's report describes the subject's research and the
     basis for the Board's findings. It is essential reading for making
     decisions concerning this case.


            he -Universityt
                          s I1Policyand Procedures for Review of Alleged
     Misconduct in Research and/or ScholarshipIt define llscholarly
     misconductt1as "fabrication, falsification, plagiarism, deception
     or other practices that seriously deviate from those that are
 I   commonly accepted within the scientific community for proposing,
 '   conducting, or reporting research [footnote omitted] or (b)
     material failure to comply with federal, state or other
     requirements that uniquely relate to the conduct of research or (c)
     misconduct in science. The university does not define llmisconduct
     in sciencen or "scientific misconductM as such.
                                page 2 of 24
I
         Because the subject was no longer employed by the University
    at the time the Special Review Board report was completed, the
    Board recommended no University action against the subject except
    that "the General Counsel . . . take the necessary legal action to
    recovern inappropriately spent funds from the subject . For the
    same reason, the IRB report recommended no actions against the
    subject.
         The Board also recommended that NSF conduct its own
    investigation and suggested that NSF might be able to elicit or
    compel the subject's cooperation. The Board recognized that its
    own investigation was hampered by the subjectls repeated failure to
    cooperate and noted that, if the subject cooperated with NSF, a
    'more complete description of the facts might be obtained. The
    Board made the following recommendation (pages 24-25) to NSF:
         On the basis of the evidence summarized in this report, the
         Board suggests imposing two of the sanctions listed in Group
         I of NSFfs misconduct regulations. . .     .
                                                   NSF should (a) send
         a letter of reprimand to [the subject]; and (b) for some
         specified period, require as a condition of future awards that
         an institutional official certify the accuracy of reports
         generated under the award and provide assurance of [the
         subjectlsl compliance with institutional, federal, and
         professional standards, policies, guidelines, regulations, or
         special terms and conditions relating to treatment of human
         subjects (including recruitment, obtaining informed consent,
         and payment), disbursement of funds, accounting, and
         maintenance of pertinent records and documents. In addition,
         on the basis of additional information that may be obtained
         upon completion of its own investigation, NSF may wish to
         consider possible sanctions listed in Group 111, including
         debarment of [the subject] from participation in NSF programs
         for some specified period.


                            OIG'S   INVESTIGATION


         Two OIG staff members, one of them a Ph.D. behavioral
    scientist, questioned the subject concerning the findings in the
    Special Review Board and IRB reports. The subject provided OIG
    with a sworn statement concerning her activities under her NSF
    award. A copy of this statement appears in Appendix 3. OIG1s
    scientist also accompanied the subject to her office at her current
    institution, where the two of them searched for records bearing on




                                page 3 of 24
    her activities under her NSF award.2       OIG also audited the
    university's expenditures under the subjectfs NSF award. A copy of
    the audit report appears in Appendix 4.
         In order to understand the evidence bearing on the
    university's conclusions in this case, it is important to
    understand the subject's research activities in 1989 (when she was
    at her former university) and early 1990 (after she had moved, in
    early January, to her new institution). During this period, the
    subject either was or claims to have been engaged in data
    collection for the following studies:

               F
               that  NSF
                           study. This is the study design that the
                  ject proposed to NSF. It is the only study design
                         agreed to fund.   It involved interviewing
               members of one hundred families with two.parents and two
               adolescent children.
         2.                                        This study   involved
                                               ool students.




              -
         3.            This study involved interviews with "three-member
                family groups composed of a female college student,
               ,        and .                             (Board report,
               page 14)
                                         -
         4.                                     This study involved
               In~erv-iews
                         with hxgh school and college students.
         5.                        This study involved interviews with
               young people about their expected   m-
         6.   .-intekiews             This study involved videotaped
                          with family groups.   It w a s designed in
               collaboration with another faculty member at the


         2~hesubject supplied copies of all relevant records that they
    could locate in her office or in storage rooms at her current
    institution. The subject had not prepared a collection of research
    records that she considered relevant in advance of OIGfs visit,
    and, to facilitate the search for relevant files, generally
?   permitted OIG1s scientist to examine her files without herself
    screening them in advance. There is no reason to believe that the
    subject either deliberately withheld relevant records or carefully
    selected only certain records in order to document her own account
    of her activities.      Indeed, she supplied many records that
    undermine her account, and she seemed imperfectly aware of the
    contents of what appeared to be long unopened boxes of files that
    she had brought with her from her former university.
                                page 4 of 24
          subjectls former university. This study was discontinued
          when the other faculty member left the subject's former
          institution.
      For a more detailed description of these studies, see the
Board report (pp.14-20). OIG believes that data for studies #2 and
# 4 were collected in 1989, as were a large part of the data for
study #3. OIG believes that, despite the subject's statements to
the contrary, the data for studies #1 and #5 were collected well
after the subject arrived at her new institution and without the
aid of her NSF award. The basis for these conclusions is discussed
below.
Evidence Bearing on the University's   Conclusions
     A summary of the evidence that relates to the five conclusions
of the Special Review Board follows.:
     1.   Misuse of    funds   set     aside   for   human   subjects
          reimbursement.
     Shortly after the subject was notified that NSF would make an
award, she sought to establish a checking account from which she
could draw funds to pay participants in her experiments. Appendix
J contains a copy of the subject's explanation to the University
Purchasing Office of why she needed this account. The subject
states:
     A critical aspect of meeting this NSF grant obligation
     involves the prompt reimbursement of research participants.
     Because obtaining the full sample for this study depends
     largely on referral of new families received from previous
     participants, it is critical that individual reimbursements be
     paid at the conclusion of completed interviews rather than
     after a lengthy delay.     Delays in payment of participant
     reimbursement would have the effect of diminishing the
     necessary referrals and undermine our ability to successfully
     complete this grant.
The subject's justification for establishing the checking account
specifically restricts the use of account funds to interviewer
travel ($300) and human subject reimbursement ($6000). The account
required special justification in part because the subject, in
furtherance of her research objectives, was asking the university,
in the words of OIG1s audit report (page 8), to depart from
"prudent business practices and good internal controls1'and thereby
to increase "the risk,ofloss or misuse of fundsu (see audit report
in Appendix 4 ) .



                           page 5 of 24
         At the Special Review Board1s request, the university1s
    internal audit staff analyzed expenditures from the subject's
    checking account (see Appendix P). During 1989, when the subject
    was at the university and, at various times, employing three
    different research assistants under the grant and receiving
    additional research assistance fromtwo other graduate students and
    several undergraduates, only four checks, totalling $20, were
    written directly to research subjects. An additional six checks,
    totalling $844, were written to the subject's research assistants,
    who told the review board that they had used this money to pay
    research subjects. The subject wrote two checks to cash, endorsed
    by herself, totalling $800, with memo lines indicating that they
    were used for subject reimbursement.
         When an OIG scientist visited the subject's office, the
"   subject produced copies of consent and assent forms signed by
    persons who participated in her.research in 1989 and receipts for
    payments to those persons. These forms and receipts relate to
    three "ancillary studiesn that are thematically similar to the
    project the subject proposed to NSF but are not included in her NSF
    proposal (These studies are referred to above [page 41 as studies
    #2, # 3 , and #4).   OIG believes that the preponderance of the
    evidence indicates that most or all of the money withdrawn from the
    checking account in 1989 was used for paying research participants
    in these ancillary studies and reimbursing interviewers for travel
    connected with these ~tudies.~


         3 ~ h econsent and assent forms and receipts that the subject
    supplied corroborate the testimony of the subject's research
    assistants (Appendix C) concerning her data collection activities.
         The amount of money charged to the checking account for
    participant reimbursement in 1989 is roughly consistent with the
    amount that would have been necessary to pay the participants from
    whom the subject obtained data and for whom she produced consent or
    assent f o m or receipts for payment.      OIG did not tally the
    receipts against the withdrawals from the bank account because we
    believe that a discrepancy would be as likely to indicate that some
    receipts were missing as it would that money was misappropriated.
         In her affidavit, the subject maintains that her 1989
    withdrawals from her checking account were made for the purpose of
    reimbursing some or all of 91 families from her former university's
    state who were interviewed for the NSF study design.            She
    acknowledges that "the amounts I withdrew for .   . . reimbursement
    from the checking account are less than those which would have been
    necessary to pay 91 families $10 or more per person. At this time
    I cannot recall where the money came from to pay the remainder of
                                                         (continued.. .)
                               page 6 of 24
             3
                 .
              ( . .continued)
        the subjects participating in the study." This claim contradicts
        the evidence on at least two counts. First, there is no evidence
        that the subject collected any significant amount of data under the
        NSF study design while she was at her former university. Second,
        both the subject' s former research assistants and the check records
        indicate that much of the money in the account was used to
        reimburse participants in the ancillary studies. On page 4 of the
        subject's affidavit (Appendix 3 ) ' she characterizes the testimony
        of the research assistant who collected data ydu
                                                       for
                                                        ts('             #3)
        as "substantially accurate." That research assistant said that she
I
        reimbursed participants in 0 research with money derived from
        the subject's checking account.
             The subject's written reports of her research are further
        evidence that she interviewed human subjects for the three
        ancillary studies and are consistent with the idea that she did so
        in 1989 and reimbursed subjects for their participation with monies




        subject's co-authorwas one of her research assistants in 1989, and
        the subject supplied assent forms and receipts for subject
        reimbursement for this study. There is, in short, overwhelming
        evidence that data for this one study was collected in 1989 at the
        subject's former university and with the aid of funds from her NSF
        grant.
             The     subiect   s u ~ ~ l i e dOIG   with   a   manuscript   entitled


        described on the title page as Inan expanded version of a paper
        presented at the annual meeting of the 0        -  J
        Associationm in 1992. This manuscript is based on the data from
              (study #3), another of the ancillary studies. A manuscript
        with a very similar title and list of authors is listed on page 11
        of the curriculum vitae that the subject supplied to us in March,
        1994 as submitted for publication.

    I        The subject supplied reimbursement receipts and assent forms
        for a study on                                         (study # 4 )
        that indicate that data collection took place in 1989.          Her
                                                           (continued. . . I
                                        page 7 of 24
     In January, 1990, the subject assumed a visiting faculty
position at her current institution. At that point, she had only
one research assistant working for her, and both the subject and
her assistant state that the assistant was not engaged in data
collection (See her Affidavit in Appendix 3 and her research
                                        .


                              -
assistant's statement in Appendix C)    Both also state that the
assistant left the subject's employ by the end of the month.
     Between February 13, 1990 and April 9, 1990, the subject
withdrew $3250 from her checking account in five checks made out to
herself and one made out to cash. Memo lines on three of the six
checks refer tofI-        one of the subject's ancillary studies.
One memo line refers to                 the subjectls label for the
study supported by NSF, and another to an unspecified "Research
studyI1 (See Appendix P).
     The subject could supply .no documentation that these
expenditures were made to reimburse research participants. In her
affidavit (page 2), she stated that "these monies went to s
reimbursement for participants in the
Study, to the best of my recolle~tion.~She produced nothing of
substance to support this claim. She supplied OIG with an undated
log with the names and addresses of 40 potential research subjects
who lived near her new institution.        Information in the log
indicates that the persons listed were potential participants in
          other evidence, however, indicates that this,log refers
to persons who, if they participated in the study, did so long
after the subject made her withdrawals from.herchecking account in
early 1990.    The subject supplied reimbursement receipts and
consent forms from participants in the study who were interviewed
after the subject moved to her new institution. All 16 such
receipts were signed by people listed in the subject log. With one
exception (a receipt dated May, 1990), these receipts are dated
between November 1990 and May 1991. The subject supplied OIG with
extensive records of data collection for two of her other ancillary
studies, and partial records for-        The research assistant who
worked o       n stated that she herself kept some of the records
for that study. The absence of any documentation to support the
subject1s claim that she collected data for           in the period
between February and April, 1990, contrasts strikingly with the
wealth of documentation she was able to supply concerning her other


     3   (   . ..continued)
curriculum vitae lists a manuscript i>y 1 0 - ,
and          on this topic; the third author is presumably the
rese-stant         of the same name who collected data for this
project in 1989. OIG did not request a copy of this manuscript.

                              page 8 of 24
    ancillary studies and her other activities with regard
    itself.
         The research assistant who did most of the data collection for
           reported to the Special Review Board that the subject
    interviewed ''about 20" persons for the study after moving to her
    new institution (Appendix C; see also ,Appendix L) .4 Neither the
    subject nor the research assistant has ever claimed that the bulk
    of the data for this study were collected by the subject once she
    arrived at her new institution; the research assistant originally
    estimated that eighty percent of the data collection was done by
    the research assistant. This claim is consistent with the numbers
    of consent and assent forms and payment receipts from participants
    who lived near the subject's new institution that the subject
    produced during the visit by OIG investigators.
         OIG believes that the preponderance of the evidence indicates
    that the subject's data collection activities for-       after she
    moved to her new institution were restricted to a small number of
    the total of 168 participants in the study. Insofar as there is
    evidence of data collection for this study, that evidence shows
    that data collection occurred either far from the subject's new
    institution or well after April, 1990. Data collection activities
    for this study cannot account for the withdrawals from the
    subject's bank account in early 1990. The subject's claims to the
    contrary are not credible.
         OIG further believes that it is wholly implausible that the
    subject could have spent this amount of money on participant
    reimbursement in this amount of time. The subject had recently
    arrived at a new institution. She had no paid research assistants
    engaged in data collection. She was thus working alone or with
    volunteers whom she had only recently met.'      Even assuming a


         4~ppendixL contains a letter from the same research assistant
"   in which she discusses her activities.       In that letter, the
    research assistant says that she cannot recall the number of
    participants that the subject interviewed after moving to her new
    institution. She also reports that she had records of at least 42
    interviews conducted before the subject's move. In the subject's
    own records of data collection for this study, OIG discovered
    consent forms and payment receipts from the research assistant
    dated after the move, indicating that the research assistant
    continued to collect data for this study after the subject
    relocated.
          he subject provided no evidence that she had recruited and
    trained the large corps of volunteers that would have been needed
    to do this work.
                               page 9 of 24
        generous rate of $20 per research participant6 and $250 for
        interviewer travel, the subject would have to have interviewed 150
        persons in two months to generate $3250 in expenses. In the




                    -
        previous calendar year, working with three paid assistants (see
        breakdown of research assistant expenditures, Appendix 5) and
        several student volunteers (see Affidavit, Appendix 3, page 3) , the
        subject collected data from approximately 250 secondary school
        students and a handful of adult^.^ She reports that her paid
        assistants were responsible for the bulk of this data collection
        (Affidavit, Appendix 3, page 2).      The study designs that her
        assistants and she executed while she was still at her former
        university had much less stringent participant selection criteria
        than either        or the study design that was proposed to NSF.
        The latter two studies required participants in specified family
        configurations, whereas the former did not.        To believe the
        subject's account would be to believe that, in contrast to her
        performance under more favorable conditions the preceding year, she
        carried out an enormous amount of data collection in a short period
        of time under a demanding research design without the aid of
        research assistants working under the grant. Although the subject
        was able to produce extensive documentation of her research and
'       expenditures for the studies performed while she was still in
        residence at her former university, she could not produce
        comparable documentation-- or, indeed, any documentation at all--
        of the activities that generated her expenditures in the early



             6 ~ h i sis much higher than in her studies at her former
        university, but using adult subjects rather than high school
        students would have necessitated a higher reimbursement rate. In
        her affidavit (appendix 3) , she says that she increased the subject
        reimbursement rate from the $10 that she proposed to NSF to $20.
             7 ~ h i sestimate is based on the assumption that data from two
        ancillary studies, one with 72 secondary school student
        participants and the other with 160 secondary school or college
        student participants, were collected entirely during 1989 at the
        subject's former university. An indeterminate number of J ,
        subjects were also interviewed during this year; a plausible
        estimate is 100, although the number might be as low as 50. A
        study of adolescents1                        -              was also
        conducted
           s i , tatn some
                         i o p                   no documentary evidence that
        this was in 1989. Data collection for this study appears to have
        been done after the subject arrived at her new institution. The
        subject maintains that she collected data from 91 four person
        families while she was still at her former institution, but OIG
    I   believes that this claim is false (see above, page 6, and below,
        page 17). There is evidence that she collected data from up to
        nine such families in 1989, however (see below, page 18).
                                   page 10 of 24
    months of 1990.   OIG believes that the subject's story is simply
    not credible.
         OIG concludes that the subject misused funds set aside for
    human subject reimbursement. She departed from the procedures for
    using her bank account that she described in the special
    justification she submitted to her former university (see
    Appendix J) in that she typically wrote checks to herself or her
    research assistants and not directly to research participants. In
    addition, although the subject states that these funds were used
    for research related purposes, we were unable to locate any
    documentary evidence to establish how the funds were actually used.
         2.   Failure to account for video equipment
         The Special Review Board report (Appendix- 1, pp. 20-21)
    contends that the subject misspent .grant funds for unnecessary
    video equipment:
         . . .   $869.39 was used to purchase a stereo television
        monitor, a video cassette recorder, a TV/VCR stand, and
        associated cables (the expenditure summary and purchase orders
        are reprinted in Appendix P). The Board could not establish
        a need for this equipment.    . . .    According to [a faculty
        collaborator] s statement (~ppendixC) , video equipment was
        used with a few pilot subjects in the study entitled 0
                                                 ."    It is not clear
        -
        i
        de
         o                  Tquipment p=by            [the subjectl was
        used with these subjects;        suitable video equipment was
        already available for use by members of [the subject's
         department] at the time of the research. According to [name],
         Chair of the Department, the equipment purchased by [the
         subject] is missing from the Department.
    This equipment, because it was purchased with grant funds, is the
    property of the subject's former university. Even if it had been
    necessary for the subjectts research, the subject would have had no
'   right to take it from the university without permission.
         On page 5 of her affidavit (Appendix 4), the subject offers
    the following account of this matter:
          The equipment I purchased (I believe with NSF funds) for the
                                                     Study [referred to
       fo-             this
                        hc-per                         included an RCA
         VCR, a VCR cart, an RCA television monitor, and two cables,
          were left by me in my lab when I came to [her new state] in
          January 1990. I do not know what happened to this equipment;
          when I went back to [the University] in June 1991 to pack up
          my lab and office, the equipment was missing. I informed [a

                              page 11 of 24
         faculty colleague] of this when we met in June 1991 to review
         which equipment belonged to me and which to [the university].
         I felt it necessary to purchase this equipment for the
                                Study because I could not perform the
                               ipment, as three sets of TVs, VCRs, and
         cables were needed, and only two were available in [the
         faculty collaborator] s lab.
    The subject further explained that other video equipment in her
    former department would not have been readily available for her
'   research, as it was housed in other laboratories and under the
    control of other researchers. From the subject's description of
    the research design in which the video equipment was to be used,
    OIG believes it is probable that the equipment was originally
    purchased for a legitimate research purpose, but not for urposes
    of executing the study design originally proposed to NSF.f'
         OIG believes that the evidence from our investigation tends to
    confinn the university1s conclusion that the subject failed "to
    secure the safekeeping" of equipment belonging to the university.
         3.   Treatment of human subjects
         The IRB at the subject's former university issued a report
    (Appendix2) concerning the subjectlsviolations of IRB guidelines.
    This report is essential reading for making decisions concerning
    this case.    The sections of the Special Review Board report
    relating to human subjects violations (Appendix 1, chiefly pages 7-
    11, page 15, and page 19 and the report appendices referred to
    therein) also provide supporting documentation for the IRB
    findings.
         Of the seven violations of IRB guidelines listed in the IRB
    report, five, in OIG1sopinion, might reasonably be seen as serious
    deviations from accepted practice in the scientific community and
    hence as misconduct in science under NSFrsdefinition. Because two
    of the IRB findings concern the same kind of violation ( # 3 and # 4 ) ,
    we have grouped them together. The serious violations are:



         'When OIG interviewed the subject at her home, OIG staff
    noticed in plain view video equipment that appeared to be identical
    to that purchased with grant funds. The subject states in her
    affidavit (Appendix 3, page 5) that "though I have an RCA VCR in my
    home which matches the description of the VCR purchased for the
    Study, I will not give [the OIG staff member] my consent to inspect
    it to determine if it is the same as that purchased under the
    grant. "
                                page 12 of 24
              1.   Failure to respond to IRB request for consent and
                   assent forms. (1)
              2.   Failure to pay research participants as promised.
                   (2
              3.   Failure to obtain written consent from two school
                   systems to perform research using their students.
                   (3) and (4)
              4.   Failure to obtain IRB approval for data collection
                   protocol. ( 7 )
    (Numbers in parentheses refer to the numbered IRB findings in
    Appendix 2). The remaining two violations, even:considering that
    human subjects regulation is generally extremely rule and detail
    oriented, cannot reasonably be construed as serious enough to
    warrant a finding of misconduct in science and will not be
    discussed further. In her affidavit, the subject discusses her
    response to the findings in the report (Appendix 3, pp. 3-41.
         Regarding the first finding, the subject admits she was
    unresponsive to her former university's IRB. She explained that a
    hostile environment and a poorly handled tenure review process had
    left her ndepressedllso that she "reacted stupidlyn (Affidavit,
    Appendix 3).
         OIG notes that there is ample documentation that the subject
    repeatedly failed to cooperate in IRB and IRB related
    investigations concerning her treatment of human subjects (see
    Special Review Board Report, pp. 1-8, and Appendices D, E, and F).
    The evidence clearly indicates that the subject knowingly failed to
    respond to legitimate information requests from her former
    university's IRB. The subject admits that she received these
    requests and did not respond to them.
         Regarding the second finding, the subject says it was
    llpossiblell
               that research participants who claimed not to have been
    paid as promised were noverlooked. She claimed that, on one of
    the several occasions on which her department chair contacted her
"   about this matter in October and November of 1990, she offered to
    pay these participants (Appendices A and G bear on this claim, but
    do not corroborate it).
         OIG' s examination of the subject's payment records revealed
    that all three complainants participated in an abortive study that
    combined the study design the subject proposed to NSF with the
"   collection and analysis of videotaped family interactions. The
    subject initiated this latter project in'conjunction with a faculty
    collaborator who left the subject's former university for another

                              page 13 of 24
    institution. For the other studies that OIG believes the subject
    conducted using funds from her NS-F awirdl9the subject has G p l e
    records of participant payment.
         OIG believes the preponderance of the evidence indicates that
    the payment problem was restricted to one abortive study. We do
    not believe there is strong evidence to relate this problem to the
    subsequent misuse of funds from the bank account the subject
    established to reimburse research participants, except insofar as
    her failure to pay the complainants meant that there was additional
    money available for misuse that remained in the account.
I        The preponderance of the evidence indicates that the subject
    was at least grossly negligent in not paying research participants
    in her study. The subject was an experienced researcher and a
    former IRB member. She was well acquainted with the rules for
    proper treatment of human subjects. Even for an aborted study, she
    should have had a system in place for maintaining records of
    research participation and sending promised-payments. She had a
    convenient source of funds in her university authorized checking
    account, but failed to use these funds for their intended purpose.
    When alerted to her failure to pay her research subjects, she did
    not act affirmatively to remedy this failure, although she may have
    made general statements of her intention to pay. Her pattern of
    action in failing to pay her research subjects shows a gross lack
    of care that OIG believes is sufficiently blameworthy to justify a
    finding of misconduct.
         Regarding the issue of school system approval, the
    preponderance of the evidence indicates that the subject failed to
    obtain approval from one school system whose students she solicited
    as research participants.1° Although the subject claims to have a


          his includes the three completed ancillary studies:
                                and V    -         -   - -
                                                                ,
                                                                ,   The
    q      1      9      8      9 with the support of her NSF grant she
    executed both the original study design she proposed to NSF and a
    study of adolescentst                                . She lacks
    documentation of participant reimbursement for these studies, but
    that, in our view, is because she did not do them when she says she
    did. It is not because she failed to pay the persons who in fact
    participated. The evidence to support OIGtsconclusions about what
    research the subject conducted in 1989, while receiving NSF
    support, is discussed below (pp.14-17).
         'Qegarding the other alleged instance of failure to obtain
    school system approval, the situation is as follows: the IRB found
    that the subject failed to get school system approval for
                                                        (continued.. .)
                               page 14 of 24
copy of an approval from the public school system near her former
university, she was unable to supply a copy of this approval. She
did supply two forms containing requests "for approval of research
study to be conducted in the [name] County schools." The subject
herself had signed these forms, but they had not been signed by an
official of the school system. She also supplied a letter, written
on)the stationery of her former department and dated January 20,
1989, addressed to an administrator at the school system in
question. This letter thanks the administrator for meeting with
the subject and expresses the subject's hope "to work with you on
the research which we disc~ssed.~ The letter describes two
projects that were discussed in the meeting: one of the ancillary
studies and the study that was proposed to NSF. While this letter
is evidence that the subject attempted to obtain school system
approval for conducting her research in the schools, it does not
show that she actually obtained such approval.
     OIG believes that the absence of a signed approval form in the
records of either the subject or the IRB at her former university
indicates that the subject did not obtain written approval and so
could not have filed an approval form as required by the IRB.
     The subject was at least grossly negligent in not obtaining
school system approval for data collection involving students and
not filing notification of approval with her university's IRB.
Researchers who collect data in schools have a responsibility to
know the importance of mintaining good relations with them and the
importance of treating them properly.          Because obtaining
documented school approval for data collection is so important,
neglecting to obtain it should not be considered merely careless.
     The finding of data collection without an approved protocol
concerns the subject's study of
(referred to on page 4 as study # 5 ) .  OIG concludes that data
collection for the study in question did not take place with the
aid of the subject's NSF award and did not take place when the
subject was at her former university, despite the subject's
testimony to the contrary. The subject has no documentary record


       . ..
     lo (  continued)
soliciting research participants at the schools near her current
institution. The subject contends that she Ifgotsubjects through
advertisements in the newspaper and in flyers, not through
schools.I'   Neither OIG nor the Special Review Board has any
substantial evidence to contradict the subject's claim on this
point;    the contrary impression seems to have developed from
remarks the subject made to university officials concerning data
collection that took place after she moved to her new institution
(see Special Review Board Report, p.11; see also Appendix GI.
                           page 15 of 24
 of consent forms or subject reimbursement for 1989 concerning this
 study, nor did any of her research assistants testify to their
 involvement in it. The subject does have published reports of data
 from this study, however.     These are co-authored by graduate
 students at her current institution and a peared long after she
 ceased spending money under her NSF award.''  Although the subject
 acknowledges NSF support for this study, we believe that, at most,
 NSF supported planning for the study and not actual data
 collection.   Because we conclude that the data collection in
 question was not aided by the NSF award, we have no reason to
 consider possible noncompliance with human subjects guidelines in
 this study.
      4.   Non-performance of research
      The Special Review Board concluded that in 1989 the subject
 did not perform the research she proposed to NSF. The evidence
 that the subject supplied to OIG during our interview tends to
 confirm this conclusion. We believe that the preponderance of the
 evidence indicates that the subject began collecting data for this
 study in the late summer or fall of 1989, but that she collected
 data from only a small number of subjects.
       The earliest written record that the subject could supply for
 a data set matching the data sek she proposed to collect under the
 study design described to NSF was a codebook dated November 25,
 1991.I2  OIG believes this codebook supports the subject's claim



 are based on this st6iy.
                               -
       h he subject supplied reprints        -
                                      of two published reports
                                                         -     that

                       --
,-                     pp. 0 ; Y n bd- w

 w;dp.in-th                   are o     -    a    u     t    h     z
 cuerent institution. In one, she describes subject recruitment as
 having taken place through newspaper and radio advertisements,
 which is consistent with how she elsewhere described. subject
 recruitment as taking place when she arrived at her new
 institution.
      121t was prepared in SPSS-PC (Statistical Package for the
 Social Sciences) format. The codebook contains a list of all the
 variables for which the subject collected data, and the variables
 listed match those that would have been collected under the study
 design proposed to NSF. The subject
 conference paper entitled     -      -


                            page 16 of 24
  that she performed the research, while at the same time
  contradicting her claim about when she did it. We do not, in other
  words, believe there is reason to think that she has fabricated
  data. We believe it is extraordinarily unlikely the subject would
  have fabricated a 1991 codebook to substantiate her claim that she
  collected these data in 1989, when she did not fabricate more




                                                               -
  direct evidence of 1989 data collection.
       The Special Review Board found that none of the subject's
  research assistants reported collecting data under the study design
  proposed to NSF. The subject supplied OIG with an article from a
  local newspaper in which she describes her research and presents
  herself as seeking suitable participants for further research. The
  subject emphasized to OIG that she had checked the article for
  accuracy before it was published. The article is dated
  1989. It represents the subject as having ttrecentlyfinishedn two
  of the ancillary studies (#2 and #4) and as having a third one ( # 3 1
  under way." It presents her as "currently looking for additional
  volunteers for her studiesttand says that "she needs approximately
  100 families for the current round of testing." This description
  is consistent with the idea that in late         1989, the subject
  had not yet b e y n collecting data under the study design she
  proposed to NSF. The subject also provided OIG a copy of a letter



                       --
I -       and 4.-      -         . This paper
                                          - -   ik identified on the
  title page
        - -   as  "a revised version  of  a poster  presented at the
  biannual meeting of the       -
                                 1993.    It contains data from "364
  participants- 91 mothers and fathers, and two of their biologically
  related children. It    This description matches the subject's
  description of the data she collected under the study design she
  proposed to NSF.
           13~hese descriptions are consistent with other evidence
      concerning the subject's data collection activities, including the
      subject's records of participant reimbursement and the signed
      consent and assent forms from these studies.
           141f this inference is correct, it further undermines the
      subject's claim in her affidavit that in 1989 she used the money
      from her subject reimbursement account to pay families that
      participated in research under the study design proposed to NSF.
      From the beginning of July, 1989, to the end of the year the
      subject withdrew $510 from that account. Of this amount, $490 was
      paid in checks to the research assistant who ran the -project
      and $20 was paid directly to subjects who participated in that
                                                                     ..
                                                          (continued. )
                                page 17 of 24
         to the same newspaper, dated                  1989, concerning an
         advertisement she wished to run to recruit research participants.
         This further supports the idea that she was early in the process of
         recruiting subjects for the NSF funded study."
              For the project that was funded by NSF, the subject supplied
         OIG with consent and assent forms signed by 27 members of nine
         families.    These forms indicate that the subject planned to
         coordinate the research plan that she had developed with her
         faculty c~llaborator'~  with her research under the NSF study
         design. The forms describe a two step data collection procedure,
         the first step of which matches the study design for the study
,        proposed to NSF and the second step of which matches the design for
         the study with the subject's faculty collaborator. The forms state
         that "each family member will be paid $10.00 for completing Phase
         I, for a possible total of $40.00 per family (i.e., both parents
         and up to two teenage children)..I1     An equivalent amount was
         promised for completion of the second phase of the study.
              Included among the consent and assent forms the subject
         supplied to OIG are the forms signed by all three of the
         complainant families. One complainant family claims that it is
         owed forty dollars, while another claims it is owed thirty dollars
         (see Appendix H) .  These amounts suggest that these families did         ' I
         not participate in both phases of the study. This is consistent             I

         with the collaboratorIs statement (Appendix C) that few if any              I

         subjects actually participated in the study that she and the
         subject designed.
              The testimony of these participants as to the research process
         was, according to the Special Review Board report, lathe only
         evidence of data collection activity on this projectn (pp. 9-10).


               ( . . .continued)
                14

         project. The research assistant, according to both the subject and
         the assistant herself, was not involved in executing the study
    I
         design the subject proposed to NSF.
               he Special Review Board was unable to locate and interview
         one of the subject's research assistants. OIG was also unable to
         locate him. This assistant left the subject's employ before July.
         We therefore believe it is highly unlikely that he collected any
         significant amount of data under the research design proposed to
         NSF.

    !I        16This is the study of
         .purchased.    It is this studmr    which the v w e q u i p m e n t was
                     The newspaper article also describes this as a study on
         which the subject was currently working.
                                     page 18 of 24
        The signed consent and assent forms do not necessarily indicate
        that the signatories actually participated in the subject's
        research; the forms indicate only that the signatories agreed to
        participate.
             OIG believes that the small number of consent and assent
        forms, the absence of research assistants who might have
        administered data collection or taken part in subject recruitment,
'       and the absence of other evidence of data collection while the
        subject was in residence at her former university make it unlikely
        that in 1989, while receiving and spending NSF grant funds, the
        subject collected the data for the project that she proposed to NSF
        and that NSF funded.
             5.   Non-Cooperation with Inquiries and Investigations.
             OIG1s investigation did not uncover additional information
I       relative to the subject's failure to cooperate with inquiries and
        investigations by her former university.       The Board report
        discusses this issue on pages 8 and 21; *further evidence can be
        found in Appendices D l E l and F.
        Evidence Bearing on an Additional Allegation
             The Special Review Board raised an additional allegation (p.
        21) by one of the subject's graduate assistants that the subject
        npersuadedher to relocate to [the subject's new institution] under
        false pretenses: by promising her admission to the school and a
        full-time salary on the NSF-funded projects. Neither promise was
        fulfilled, and [the student] claims she is owed $1400 for services
        rendered.
             Because this allegation relies on the testimony of the
        parties, and cannot, for the most part, be verified by documentary
    "   evidence, it is a difficult allegation to substantiate and relies
        heavily for substantiation on the complainant's credibility.
             In her affidavit (Appendix 3, page 4), the .subject disputes
        the student's account of the events that took place after the
        student moved to the subject's new state and resumed working on the
        subject's research project. She states that the student "never had
        an intention of enrollingn at the subjectls current institutionvv
        and "after the summer of 1989, she had decided to discontinue
        graduate studies in           Iv at the subjectls former university.
        The subject told OIG-gators            that the student was planning
        to apply to medical school and had been taking pre-medical courses.
        OIG obtained a copy of the student's transcript and verified that
        the student was taking pre-medical courses and not
        courses in her final semester at the subject's former-u


                                  page 19 of 24
         OIG believes that this evidence casts sufficient doubt on the
    credibility of the student's claims of non-payment to make it
    impossible to meet the burden of proof necessary to substantiate
    this allegation.l7
    OIG8s Conclusion Regarding Misconduct in Science
         NSF defines misconduct in part as llfabrication,falsification,
    plagiarism, or other serious deviation from accepted practices in
    proposing, carrying out, or reporting results from activities
    funded by NSFn ( § 689.1(a) (1)).
         OIG1s investigation addressed those acts of the subject that
    fall within this definition, those acts that her former university
    considered to be "scientific misc~nduct,~      and one additional
    allegation noted by the Special Review Board.        Following the
    university's recommendation, O I G interviewed the subject and
    examined her research records.        The additional information
    generated by our investigation, while it has led us to revise or
    expand upon some of the university's . factual findings, does not
    cause us to question their overall conclusions. Specifically, we
,   agree with the university that the subject violated the usual and
    customary practices for treating human subjects, misused grant
    funds, failed to secure the safekeeping of university owned
    equipment purchased under the grant, failed to use her NSF award to
    conduct the study she proposed to NSF, and refused to cooperate
    with inquiries and investigations into the allegations directed at
    her.
         We share the university's view that, taken together, the
    subject's failures to comply with human subjects regulations are a
    serious deviation from accepted practices for the treatment of
    human subjects ( § 689.1 (a)(1)) and constitute misconduct as defined
    in NSF1s regulation on misconduct in science and engineering.
         OIG believes that the subject's failure to respond to IRB
    requests for information, failure to pay research participants as
    promised, and failure to obtain school system approval for research
    using the system's student population seriously deviate from
    accepted practice in the community of researchers that studies
    human beings. Condoning acts such as these would undermine the
    authority of the system of human subjects regulation that the
    federal government supports and oversees, erode the trust necessary


          his is not to say that OIG accepts that the subject's
    account is therefore accurate. We clearly have ample reason to
    question the subjectls credibility as well. We simply concluded
    that this allegation was unproven and unprovable.

                               page 20 of 24
         for researchers to recruit subjects for their research, and
!        ultimately threaten research subjects with significant harm. At
         the time when the subject's NSF supported research was conducted,
         NSF1s definitTon of misconduct (45 CFR § 689.1 (a)) specifically
         included "material failure to comply with Federal requirements for
         protection of researchers, human subjects, or the public.w18
              All institutions that receive federal funds to perform
         research involving human subjects are required to have IRBs that
         set guidelines for the proper conduct of such research and monitor
         compliance with those guidelines. The primary activity of IRBs is
         to educate researchers at their institutions about the proper
         treatment of human subjects and to work with them to develop
         research protocols that enable scientists to achieve their research
         objectives while protecting the interests of human subjects.
              OIG believes that federally mandated IRBs are at the core of
         the effort to protect human subjects .from abuse and that repeated
         failure to cooperate with a legitimate request from an IRB can be
         misconduct in science. We believe that the subject's failure to
         cooperate with her former university's IRB is her most serious
         violation of human subjects regulations. We note that the Office
         for the Protection from Research Risks (OPRR) at the U.S.
         Department of Health and Human Services (HHS), which oversees
    "    federally funded research involving human subjects, stresses that


                his language was dropped in May, 1991, and was therefore no
         longer part of the definition when the Special Review Board and the
         IRB carried out their investigations. In the Federal Register, NSF
         explained that the language was omitted because it was deemed
         nunnecessary.n It characterized the deleted types of misconduct as
         "either . . , subject to other enforcement procedures and penalties
         or . . . covered by the 'other serious deviation from accepted
         practices1 language in the first clause of the definition of
    '1   misconduct. (Vol. 56, No. 30, February 13, 1991). Thus the history
         of NSF's definition of misconduct supports the idea that serious
         violations of rules protecting human subjects are included in the
         definition.
              Sanctions against individual investigators have overwhelmingly
         been left to the IRBs, which have acted without direct federal
         government involvement. Where, as in the subject's case, an
         investigator moves to a new institution, however, the I R B of the
         former institution is powerless to take meaningful action . In such
         situations, only the granting agency can act to uphold the IRB1s
         authority. The subject' s actions clearly are not covered by "other
         -enforcement procedures and penaltiesn that were referenced in the
         Federal Register when the wording of NSF1s misconduct regulation
         was changed.
                                    page 21 of 24
investigator noncompliance with legitimate IRB requests is a
serious matter:
     The most common lapses in investigator compliance include
     unreported changes in protocols, misuse or nonuse of the
     informed consent document, and failure to submit protocols to
     the IRB in a timely fashion.      .  .  .  'Occasionally, an
     investigator will either avoid or ignore an IRE, Such cases
     present a more serious challenge to the IRE and to the
     institution, Regardless of investigator intent, unapproved
     research involving human subjects places those subjects at an
     unacceptable risk. When unapproved research is discovered,
     the IRB and the institution should act promptly to halt the
     research, assure remedial action regarding any breach of
     regulatory or institutional human subject protection
     requirements, and address the question of the investigator's
     fitness to conduct human subject research. Beyond the obvious
     need to protect the rights and welfare of research subjects,
     the credibility of the IRB is clearly at stake. [emphasis
     added] .l9
     OIG believes that keeping promises to research subjects and
obtaining informed consent from institutions that control access to
subjects are core IRB concerns and core aspects of respecting the
dignity of research subjects. Failures in these areas can also be
considered misconduct.      The consequences of the subject s
wrongdoing go beyond the sheer loss of money by a small number of
research participants 'because the subject's acts challenge
important and generally recognized principles for how human
subjects ought to be treated.
     OIG believes that the preponderance of the evidence supports
the findings that the subject committed culpable acts and that she
did so with a culpable state of mind. OIG concludes that the
subject committed misconduct as defined in NSF1s regulation on
Misconduct in Science and Engineering and recommends that NSF make
a finding to that effect.

                  OIG' S RECO-ED.    DISPOSITION
     When NSF makes a finding of misconduct, it must consider the
seriousness of the misconduct in determining what actions it should
take ( § 689.2(b)) .  This includes considering the state of mind
with which the subject committed misconduct and whether the
misconduct IVwasan isolated event or part of a pattern.IV We have


     190~~12,Protecting Human Research Subjects:     Institutional
Review Board Guidebook, 1-15-16 (1993).
                           page 22 of 24
already explained that we conclude that the subject's human
subjects violations are a serious deviation from accepted practice
and hence are misconduct; this section explains OIG's recommended
actions in light of our assessment of the seriousness of the
subject's misconduct, i.e., of how serious this instance of
misconduct is in relation to other instances.
     We believe that the subject's failure to respond to her former
university's IRB and to act affirmatively to rectify complaints
from human subjects is serious. The subject's actions broke faith
with both her research subjects who were not paid and with the
community of researchers who study human subjects. It is not
merely a bending of established rules, as when the subject's
research assistant elicited consent orally rather than in writing
or when the subject failed to obtain permission to do research from
all relevant IRBs. The subject has clearly challenged key tenets
of human subjects protection, even though the harm to individual
subjects that resulted was relatively small.
     We do not believe that the subject committed her misconduct
out of deliberate contempt for either human subjects or human
subjects regulation. This would be a far more serious offense if
it were motivated by such contempt. Rather, we believe the offense
was a by product of the subject's alienation from her former
university and her desire to avoid confronting her own financial
transgressions.    We do not in any way believe that these
motivations excuse the subject's actions.
     We do not believe that the non-payment of research
participants was part of a pattern of non-payment. When we read
the Special Review Board report, we thought it likely that many
subjects were not paid, but did not complain. The evidence we
developed in our interview with the subject and our examination of
her files leads us to conclude that the three complainant families
were among a very small number of families interviewed for an
aborted study and are not symptomatic of a pattern of non-payment .
of subjects. In the studies the subject executed in 1989 at her
former university, she otherwise appears to have paid her subjects.
        We also believe, however, that the subject manifests a pattern
( f i 689 - 2(b)(3)) of non-compliance with NSF grant conditions that
warrants special attention if and when the subject receives another
grant. There are numerous indications of this non-compliance: her
decision to use the NSF grant to perform her ancillary studies,
rather than to follow the study design she proposed to NSF; her
misuse of funds from a bank account that was specially designed to
enable her to compensate research participants; and her failure to



                           page 23 of 24
         secure the safekeeping or return of equipment that was the property
         of her former university are the outstanding examples.20
              Because we believe that the subject's non-compliance with
a
         rules for the protection of human subjects is part of a pattern of
         non-compliance with NSF grant conditions, we recommend that NSF
         take special steps to ensure that the subject comply with NSF grant
         conditions in the event that she receives another award. We do not
         believe the subject's misconduct should prevent her from competing
         for future awards. However, we recommend that until January, 1998,
         before NSF makes an award in which the subject is named principal
         investigator, NSF management should require that the grantee
         institution establish special procedures to monitor the subject's
         compliance with NSF's grant conditions. These procedures should
         include, but should not necessarily be limited to, procedures for
         monitoring her compliance with human subjects regulations at the
         grantee institution.
              We recommend a finding of misconduct under NSF' s Regulation on
         Misconduct in Science and Engineering. We recommend two actions by
         NSF in response to the subject's misconduct. The subject should be
    11   sent a letter of reprimand, which is a Group I action (see
         § 689 2 a 1   (i)). If the subject is named principal investigator
         on an NSF award, NSF should require that the grantee institution
         establish special procedures to monitor the subject's compliance
         with NSF's grant conditions (see preceding paragraph). This may
         involve a combination of Group I and Group I1 actions (see
         § 689.2(a)(l)(ii), § 689.2(a)(l)(iii), and § 689,2(a)(2)(ii)). We
         believe these actions adequately protect NSFrs interests and are
         proportionate to the misconduct by the subject.




              *%e note that the subject appears to have communicated her
         casual attitude to the rules of the scientific community to her
         research assistant, who responded by unilaterally altering IRB
         approved procedures for obtaining consent from research
         participants (see IRB finding #6, Appendix 2).
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